Assessment times for notifications of clinical trial applications in 2009

According to an agreement with the industry, the Danish Medicines Agency must handle applications for authorisation of clinical trials within 30 working days. The chart shows the case handling times for applications received by the Danish Medicines Agency during each month of 2009.

• The green bar of the chart represents the cases in which the time limit of 30 days is observed. The common European time limit for handling applications is 60 days, which corresponds to approximately 45 working days.
• The yellow bar represents the cases completed within 31-45 working days.
• The red bar represents the cases in which the maximum case handling time of 45 working days is exceeded.

The case handling time is calculated from the day when the Danish Medicines Agency receives a valid application. This date is registered as the “start time” of the application.

The Danish Medicines Agency sends a receipt immediately after receipt of the application. It will appear from the application whether a review has given rise to any remarks. The application is regarded as valid if there are no remarks. The “end date” is the day when the Danish Medicines Agency sends the first reply to the notifier. This is the end date registered for each month in the chart. Hence, a case completed in February is not necessarily notified to the Agency in February, but it may, for example, be notified in December 2008.

Download diagram and data on clinical trials 2009 in Excel format (Excel-file, opens i a new window).